A data-rich 2017 positions RepliCel for
maturity through the next phase of its product development,
research programs, and revenue generation
VANCOUVER, May 25, 2017 /CNW/ - RepliCel Life Sciences
Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) ("RepliCel" or the
"Company"), a regenerative medicine company addressing large-market
opportunities with innovative technologies in aesthetics and sports
injury/orthopedics, today unveiled its go-forward strategy.
In the first few months of 2017, the Company made pivotal
announcements based on data collected from all three of its cell
therapy programs. Furthermore, RepliCel continues to make
significant progress on its nearest-term commercial asset, the
dermal injector (RCI-02).
Building on a decade of the Company's discovery, pre-clinical
work, and successful first-in-human clinical data, RepliCel has
formulated a strategic plan for 2017 through 2019 focused on
maturing its assets through three distinct pillars:
- commercializing the Company's dermal injector;
- research and development to enhance clinical efficacy, optimize
manufacturing, and strengthen the Company's intellectual property
portfolio; and
- preparing and launching phase II clinical trials.
The plan includes several key milestones anticipated to be part
of the Company's next 30 months including:
- building and testing the commercial-grade prototypes of
RepliCel's next-generation dermal injector;
- preparing the RCI-02 device for marketing approval in
Europe (CE-mark);
- executing an application-focused commercialization agreement
for RCI-02 with a multi-national partner, including the payment of
non-dilutive licensing/milestone fees and ongoing sales
royalties;
- launching and executing a molecular marker study anticipated to
add significant value to the Company's intellectual property,
manufacturing technologies, and the enhancement of clinical
efficacy;
- completing ongoing research related to the manufacture of
dermal sheath cup cells as a precursor to phase II clinical trials
of RCH-01; and
- preparing for phase II clinical studies of the RCT-01
(tendinopathy) and RCS-01 (skin aging) clinical programs.
Further details on each of the programs are expected to be
released in the coming few weeks.
"The first decade of RepliCel's growth was focused on moving our
initial discoveries through pre-clinical research, diversification,
and achieving proof-of-concept data in first-in-human clinical
trials. Now we are presented with the exciting opportunity to
mature the Company and its assets through device commercialization,
next-phase clinical trials, and partnerships," stated RepliCel's
President & CEO, R. Lee
Buckler.
"Given the near-term commercial status of our dermal injector
development and the nature of the discussions underway, we remain
confident we will secure a revenue-generating, commercialization
partnership for this asset next year," continued Buckler.
"Additionally, we are currently engaged in a number of early-stage
partnership and collaboration discussions for each of our cell
therapy programs. While we have already commenced planning
preparation for our next-phase clinical trials, these discussions
may influence how we prioritize and finance these studies.
Shareholders should expect a series of releases over the next few
weeks providing more clarity on each of these programs."
About RepliCel Life Sciences
RepliCel is a
regenerative medicine company focused on aesthetics and sports
injury applications.
As its nearest-term commercial asset, RepliCel is developing a
next-generation dermal injection device (RCI-02) designed to
optimize aesthetic injections. The Company's cell therapy product
pipeline is comprised of three clinical-stage products: RCT-01 for
tendon regeneration, RCS-01 for skin rejuvenation, and RCH-01 for
hair restoration which is being co-developed under exclusive
license by Shiseido Company for certain Asian countries.
All product candidates are based on RepliCel's innovative
technology, utilizing cell populations isolated from a patient's
healthy hair follicles.
Visit www.replicel.com for additional information.
Forward-looking information
This press release
contains forward-looking statements and information that involve
various risks and uncertainties regarding future events, including,
but not limited to, statements (i) that it obtain the approvals
required to commercialize its initial dermal injector; (ii) that
its research and development will enhance clinical efficacy,
optimize manufacturing and strengthen the Company's intellectual
property portfolio; (iii) that it will prepare and launch phase 2
clinical trials; (iv) that it will finish building and testing the
commercial-grade prototypes of its next-generation dermal injector;
(v) that it will prepare the RCI-02 device for marketing approval
in Europe (CE-mark); (vi) that it
will execute a commercialization agreement for RCI-02 with a
multi-national partner and generate revenue in the next year,
including the payment of non-dilutive licensing/milestone fees and
ongoing sales royalties; and (vii) that it launch and execute one
or more molecular market studies to add significant value to the
Company's intellectual property, manufacturing technologies, and
the enhancement of clinical efficacy. These statements are
only predictions and involve known and unknown risks which may
cause actual results and the Company's plans and objectives to
differ materially from those expressed in the forward-looking
statements, including: the risk that the Company will not obtain CE
mark clearance or other necessary regulatory approvals; the risk
that the Company's patents will not be granted or validated in one
or more countries; the risk that its phase 2 clinical trial
programs are not approved by the applicable regualtory authorities;
the risk that there will be delays enrolling clinical trial
participants; the risk that the Company will receive negative
results from the Company's clinical trials; the effects of
government regulation on the Company's business; risks associated
with the Company obtaining approval for its clinical trial in
Germany; risks associated with the
Company obtaining all necessary regulatory approvals for its
various programs in Canada, the
USA and Germany; risks associated with the Company's
ability to obtain and protect rights to its intellectual property;
risks with identifying and coming to an agreement to commericalize
its dermal injector; risks and uncertainties associated with the
Company's ability to raise additional capital; and other factors
beyond the Company's control. Although the Company believes that
the expectations reflected in the forward-looking statements are
reasonable, it cannot guarantee future results, levels of activity
or performance. Further, any forward-looking statement speaks only
as of the date on which such statement is made and, except as
required by applicable law, the Company undertakes no obligation to
update any forward-looking statement to reflect events or
circumstances after the date on which such statement is made or to
reflect the occurrence of unanticipated events. New factors emerge
from time to time, and it is not possible for management to predict
all of such factors and to assess in advance the impact of such
factors on the Company's business or the extent to which any
factor, or combination of factors, may cause actual results to
differ materially from those contained in any forward-looking
statement. Readers should consult all of the information set forth
herein and should also refer to the risk factor disclosure outlined
in the Company's annual report on Form 20-F for the fiscal year
ended December 31, 2015 and other
periodic reports filed from time-to-time with the Securities and
Exchange Commission on Edgar at www.sec.gov and with the
British Columbia Securities Commission on SEDAR
at www.sedar.com.
Neither TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in policies of the TSX Venture
Exchange) accepts responsibility for the adequacy or accuracy of
this release.
SOURCE RepliCel Life Sciences Inc.